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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01684345




Registration number
NCT01684345
Ethics application status
Date submitted
10/09/2012
Date registered
12/09/2012
Date last updated
8/04/2016

Titles & IDs
Public title
Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis
Scientific title
A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis
Secondary ID [1] 0 0
2012-001610-42
Secondary ID [2] 0 0
X052130/CL3-78989-005
Universal Trial Number (UTN)
Trial acronym
EYEGUARD™-A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uveitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Dose 1 gevokizumab
Treatment: Drugs - Dose 2 gevokizumab

Placebo comparator: Placebo -

Experimental: Dose 1 gevokizumab -

Experimental: Dose 2 gevokizumab -


Treatment: Drugs: Placebo
Solution for subcutaneous injection

Treatment: Drugs: Dose 1 gevokizumab
Solution for subcutaneous injection

Treatment: Drugs: Dose 2 gevokizumab
Solution for subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of responders at Day 56
Timepoint [1] 0 0
Day 56

Eligibility
Key inclusion criteria
* Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
* Active uveitic disease in at least one eye
* Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication
* Effective contraceptive measures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Infectious uveitis and masquerade syndromes
* Isolated anterior uveitis
* Contraindication to mydriatics
* History of allergic or anaphylactic reactions to monoclonal antibodies
* Active tuberculosis disease
* History of recurrent infection or predisposition to infection; active ocular infection
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- East Melbourne
Recruitment hospital [3] 0 0
- Nedlands
Recruitment hospital [4] 0 0
- Darlinghurst, New South Wales
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Nedlands
Recruitment postcode(s) [4] 0 0
- Darlinghurst, New South Wales
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
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Indiana
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United States of America
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Iowa
Country [11] 0 0
United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Minnesota
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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Nebraska
Country [19] 0 0
United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
Country [30] 0 0
Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Armenia
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Yerevan
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Austria
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Graz
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Austria
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Salzburg
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Austria
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Wien
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Brazil
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Belo Horizonte, Minas Gerais
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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China
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Beijing
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China
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Chongqing
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China
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Hong Kong
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France
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Nantes
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France
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Paris
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Germany
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Berlin
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Germany
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Chemnitz
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Germany
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Heidelberg
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Germany
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Muenster
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Germany
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Tüebingen
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Greece
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Mezourlo, Larissa
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Israel
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Jerusalem
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Israel
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Petoch Tikvah
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Israel
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Tel Aviv
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Korea, Republic of
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SEL
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Leon
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Mexico
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Mexico City
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Mexico
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Tijuana
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Lublin
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Poland
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Warszawa
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Russian Federation
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Khabarovsk
Country [67] 0 0
Russian Federation
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Novosibirsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Saint-Petersburg
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South Africa
State/province [69] 0 0
Durban
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South Africa
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Johannesburg, Gauteng
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona
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Spain
State/province [72] 0 0
Granada
Country [73] 0 0
Spain
State/province [73] 0 0
Leon
Country [74] 0 0
Spain
State/province [74] 0 0
Madrid
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Spain
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Malaga
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Taiwan
State/province [76] 0 0
Taoyuan
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Taiwan
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Taïpeï City
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Tunisia
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Monastir
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Turkey
State/province [79] 0 0
Ankara
Country [80] 0 0
Turkey
State/province [80] 0 0
Istanbul
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Tyne and Wear
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Bristol
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Liverpool
Country [84] 0 0
United Kingdom
State/province [84] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
XOMA (US) LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Institut de Recherches Internationales Servier
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01684345